From prototype to FDA clearance to market. One senior team.

Regulatory leadership

Your acting VP Regulatory. FDA pathway and predicate decisions, the Pre-Submission, evidence strategy and quality-system readiness, until a full-time hire makes sense.

Medical device cybersecurity

The security file FDA requires for any connected or software device, and readiness for US hospital security reviews.

Strategy and go-to-market

Tie the regulatory path to your financing plan, your investor story, US market entry and the eventual acquirer.

FDA clearances at three companies

More than a dozen 510(k) submissions, including AI-based medical software, plus PMA experience across imaging and respiratory devices.

Two companies sold to global strategics

We have sat in your chair, from first prototype to acquisition.

Regulation and security, planned together

By people who have delivered both for the same product.

What we cover

Pathway and claim strategy

510(k), De Novo or PMA. Predicate selection, intended use and the first claim, chosen with your financing plan in mind.

Pre-Submission and FDA dialogue

Which questions to ask, how to frame them, and a senior voice next to your CEO in the meeting.

Evidence and clinical strategy

The bench and clinical data FDA will expect, staged against your funding. For AI: validation and a change-control plan.

Quality system readiness

A senior review against the QMSR and ISO 13485: what an investigator will ask to see, and what can wait.

Cybersecurity for FDA and hospitals

Threat model, security architecture and software bill of materials, plus answers to the HIPAA and SOC 2 questions US buyers ask.

Investor and acquirer readiness

A regulatory and security story that stands up in diligence, from people who have been through acquisitions themselves.

Ways to start

FDA Readiness Review, 2 to 3 weeks

Pathway, evidence gaps, Pre-Submission plan, timeline and budget. Ends with a readout to your board.

Cyber Readiness Review, 2 to 3 weeks

Threat model and architecture review against FDA expectations.

Pre-Sub Lead, 4 to 8 weeks

We shape the questions and the package strategy, and lead the FDA meeting with you.

Second opinion, 1 to 2 weeks

An independent regulatory and security read before a financing round, a partnership or a sale.

Acting VP Regulatory, monthly

Senior ownership of your FDA path, a few days a month.

Not sure where to start?

Tell us the next FDA decision on your table, and we will tell you honestly whether we can help.

Start a conversation